ALFApump System Versus Standard of Care in Ascites Treatment

Phase 3

Completed

• Conditions: Refractory or Recurrent Ascites
• Interventions: Procedure: Large volume paracentesis for removal of ascites; Device: ALFApump removal of ascites

• Registration Number: NCT01528410
• Lead Sponsor: Sequana Medical N.V.

Brief Summary

This is a multicentre, open, randomised, and controlled trial conducted in sixty (60) patients diagnosed with refractory or recurrent ascites. Patients will be randomised (enrolled) to either treatment arm A- implanted with the ALFApump System or treatment arm B-standard of care with evacuation large volume paracentesis. The main aims of the study are to determine the paracentesis free survival, defined as the time to the first large volume therapeutic paracentesis \> 5 litres. The secondary aims are to assess non-inferiority of cirrhosis-related complications in the group of patients randomized to the ALFApump system group, as well as nutritional effects, resource utilisation, patient quality of life and survival non-inferiority.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-31
• Study First Submitted QC: 2012-02-07
• Study First Posted: 2012-02-08
• Study Start: 2012-08-17
• Primary Completion: 2016-09-21
• Study Completion: 2016-09-21
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-12
• Last Update Posted: 2017-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

1. Males and non-pregnant females (determined by serum pregnancy test) ≥ 18 years of age. Women of childbearing age must be prepared to use at least 1 effective (≤ 1% failure rate) method of contraception during the course of the study
2. Cirrhosis of the liver defined by histological and/or clinical, and/or radiological criteria
3. Presenting refractory or recurrent ascites and requiring periodic large volume paracentesis (large volume defined as > 5 L to accord with teh clinical guidance of EASL, European Association for the Study of the Liver, which recommends withdrawal of 5 L should precipitate administration of albumin).
4. Capable of giving written informed consent, willing to comply with study procedures and ability to operate the device

Exclusion Criteria

1. Gastrointestinal haemorrhage over the last 7 days
2. Renal failure defined as serum creatinine higher than or equal to 2 mg/dl
3. Severe coagulopathy defined as prothrombin time greater than 40% more than upper limit of Normal (as determined locally).
4. Platelet count of less than 40000 /uL unless platelet therapy is given at the time of surgery
5. Clinical Evidence of recurring bacterial peritonitis, defined as 2 or more episodes over the last 6 months or a single episode within the last 2 weeks.
6. Clinical evidence of recurring urinary infections, defined as 2 or more episodes over the last 6 months or a single episode within the last 2 weeks.
7. Clinical evidence of loculated ascites.
8. Advanced hepatocarcinoma, defined as one which exceeds Milan criteria.
9. Obstructive uropathy, residual urinary volume exceeding 100 ml, or any bladder anomaly which might contraindicate implantation of the device.
10. Concurrently implanted with any other Active Implantable Medical Device, including, but not limited to, cardiac pacemaker or cardioverter defibrillator.
11. Pregnant females or females anticipating pregnancy during study period
12. Patients currently enrolled in another interventional clinical study
13. Other concomitant disease or condition likely to significantly decrease life expectancy or present anaesthetic risk (e.g., moderate to severe congestive heart failure)
14. Known presence of human immunodeficiency virus (HIV)
15. Immuno-modulatory treatment (including azothioprine, methotrexate, anti-TNF therapies) used within last 4 months
16. Known or suspected hepatic or extra hepatic malignancy, unless adequately treated or in complete remission for ≥ 3 years
17. BMI > 40 presenting a risk for surgery and tunneled lines
18. Patients with contraindications for general anesthesia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Large volume paracentesis for removal of ascites	Large volume paracentesis for removal of ascites	Removal of ascites
ALFApump removal of ascites	ALFApump removal of ascites	Removal of ascites

Primary Outcome Measures

Name	Time	Method
Paracentesis free survival	6 months	Paracentesis-free survival, defined as time to first large volume therapeutic paracentesis \> 5 litres

Secondary Outcome Measures

Name	Time	Method
Quality of Life	6 months
Survival	6 months
Nutritional profile	6 months
Non-inferiority of cirrhosis related complication in the patient group treated with the ALFApump system	6 months	Cirrhosis-related complications
Assess the need for repeat evacuation paracentesis	6 months
Body weight	6 months
Resource utilisation	6 months

Trial Locations

Locations (7)

Bristol Royal Infirmary; 🇬🇧 Bristol, United Kingdom

Centre Hospitalier Universitaire de Toulouse; 🇫🇷 Toulouse, France

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain

Azienda Ospedaliera di Padova; 🇮🇹 Padova, Italy

Royal Free Hospital; 🇬🇧 London, United Kingdom

Vienna General Hospital and Medical School, AKH; 🇦🇹 Vienna, Austria

Hopital Beaujon; 🇫🇷 Clichy, Paris, France